UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011016
Receipt number R000012897
Scientific Title Examination to identify the relationship between temperature/soaking time of the Ivermectin whole body method and transition to horny layer
Date of disclosure of the study information 2013/06/22
Last modified on 2014/12/24 23:02:16

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Basic information

Public title

Examination to identify the relationship between temperature/soaking time of the Ivermectin whole body method and transition to horny layer

Acronym

Ivermectin partial body bath test for healthy adults

Scientific Title

Examination to identify the relationship between temperature/soaking time of the Ivermectin whole body method and transition to horny layer

Scientific Title:Acronym

Ivermectin partial body bath test for healthy adults

Region

Japan


Condition

Condition

scabies

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In order to verify the safety and efficacy of the Ivermectin whole body bath method, this study is designed to examine the effect of difference in temperature/ soaking time/ bath agent on the concentration of Ivermectin transited to horny layer by bathing forearm in Ivermectin solution.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Effects of difference in temperature/ soaking time/ bath agent on the concentration of Ivermectin transited to horny layer

Key secondary outcomes

Identification of adverse events by examined drug


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Prepare the Ivermectin whole body bath solution by melting a half tablet of Stromectol® 3mg per 10 liters of hot water (in which baby bath agent is added). This solution is used for partial body bathing.
Partial body bath test is conducted five times; two of them are for investigating soaking time; two of them are for investigating bath agent; one of them is for identifying the effect of elapsed time after bathing.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Healthy and over age of 20
2) Have written consent on subjects' free will after being completely explained about this study

Key exclusion criteria

1) The patient who has an obstacle in the barrier of the skin according to a skin disorder
2) Those who have the following diseases in the past or the present
- Liver disease
- The disease considered to affect a test result by a doctor in attendance in addition to this, or the disease considered that medication of ivermectin brings about a disadvantage
3) The superfluous ingestion person of the coffee containing caffeine, or a drink (>8 cup / day)
4) The abuse person of medicine or alcohol
5) The addict of an illegal drug
6) The woman who offered the blood of 400mL within the man and woman who offered the blood of 200mL within four weeks before the examination or the man who offered the blood of 400mL within 12 weeks, and 16 weeks
7) Those who participated in four weeks to the clinical test using other investigational new drugs before this start of test
8) Those who have an anamnesis of hypersensitivity in the ingredient of a Stromectol&reg; Tablets or the charge of baby purification (Pigeon, Inc.)
9) The woman, the child below 15 km who have become pregnant
10) Those whom the examination doctor in attendance judged to be unsuitable as a subject
11) Those who have used medication within a week

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayo Komoda

Organization

Tokyo University of Science

Division name

Faculty of Pharmaceutical Sciences

Zip code


Address

2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan

TEL

04-7121-4134

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masayo Komoda

Organization

Tokyo University of Science

Division name

Faculty of Pharmaceutical Sciences

Zip code


Address

2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan

TEL

04-7121-4134

Homepage URL


Email

komo1207@rs.noda.tus.ac.jp


Sponsor or person

Institute

Tokyo University of Science

Institute

Department

Personal name



Funding Source

Organization

Tokyo University of Science

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 22 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 03 Month 08 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 21 Day

Last follow-up date

2013 Year 12 Month 21 Day

Date of closure to data entry

2013 Year 12 Month 21 Day

Date trial data considered complete

2013 Year 12 Month 21 Day

Date analysis concluded

2014 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 06 Month 22 Day

Last modified on

2014 Year 12 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012897


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name